Surgical TechniquesNCT01093430
Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?
A study testing Anterior superior iliac spine in people with Surgical Techniques and Laparoscopy, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to study port symmetry and the incidence of anterior abdominal wall neuropathy associated with gynaecological surgery. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Surgical Techniques, Laparoscopy
- What is being tested?
- Anterior superior iliac spine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Due to undergo elective gynaecological surgery, including laparoscopy
Who cannot join
- Previous laparoscopy
- Junior intern as primary surgeon
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital
London, NW3 2QG
Adam Magos, MD FRCOG, +44 20 7794 0500 ext. 33863, a.magos@medsch.ucl.ac.uk
Adam Magos, MD FRCOG
About this study
Official title: Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry
The purpose of this study is to study port symmetry and the incidence of anterior abdominal wall neuropathy associated with gynaecological surgery.
Read the detailed description
We plan to study patients undergoing gynaecological laparoscopy. Patients will be randomized to two techniques for determining where to position the right and left lateral laparoscopic ports, and port symmetry will be assessed at the end of surgery. We also plan to study patients undergoing any type of gynaecological surgery to determine the incidence of sensory neuropathy involving the lower abdomen according to the route of surgery.
- Conditions
- Surgical Techniques, Laparoscopy
- Being tested
- Anterior superior iliac spine, Control
- Keywords
- Gynecological surgery, laparoscopic ports, neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior superior iliac spineProcedure or surgery
Also called Bony landmark
The position of the right and left laparoscopic port sites will be determined by palpation of the nearby anterior superior iliac spine of the pelvic bone.
ControlProcedure or surgery
Also called Visual
The position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| Anterior superior iliac spine | Experimental | The position of the right and left laparoscopic port sites will be determined by palpation of the nearby anterior superior iliac spine of the pelvic bone. Receives: Procedure: Anterior superior iliac spine |
| Control | Active comparator | The position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symmetry of lateral laparoscopic ports
The precise location in the horizontal and vertical planes of the right and left lateral port sites will be measured to assess port symmetry.
Measured: On the completion of laparoscopy and before the general anaesthetic is reversed
Secondary outcomes (1)
Neuropathy
Evidence of ilio-hypogastric and ilio-inguinal neuropathy will be sought at the above time frames.
Measured: Before, immediately after and 2 weeks after gynaecological surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hampstead NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Adam Magos, MD FRCOG, Principal investigator, Royal Free Hamsptead NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093430
- Sponsor's protocol ID
- AM2009/1
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry
- ClinicalTrials.gov ID
- NCT01093430
- Acronym / sponsor ID
- AM2009/1
- Conditions
- Surgical Techniques, Laparoscopy
- Keywords
- Gynecological surgery, laparoscopic ports, neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Royal Free Hampstead NHS TrustUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study port symmetry and the incidence of anterior abdominal wall neuropathy associated with gynaecological surgery.
Detailed description
We plan to study patients undergoing gynaecological laparoscopy. Patients will be randomized to two techniques for determining where to position the right and left lateral laparoscopic ports, and port symmetry will be assessed at the end of surgery. We also plan to study patients undergoing any type of gynaecological surgery to determine the incidence of sensory neuropathy involving the lower abdomen according to the route of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior superior iliac spine | Experimental | Procedure: Anterior superior iliac spineThe position of the right and left laparoscopic port sites will be determined by palpation of the nearby anterior superior iliac spine of the pelvic bone. |
| Control | Active comparator | Procedure: ControlThe position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Due to undergo elective gynaecological surgery, including laparoscopy
Key exclusion criteria (2 listed)
- Previous laparoscopy
- Junior intern as primary surgeon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior superior iliac spineAlso: Bony landmarkThe position of the right and left laparoscopic port sites will be determined by palpation of the nearby anterior superior iliac spine of the pelvic bone. | Procedure or surgery | Anterior superior iliac spine |
| ControlAlso: VisualThe position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall. | Procedure or surgery | Control |
Primary outcome
Symmetry of lateral laparoscopic ports
Time frame: On the completion of laparoscopy and before the general anaesthetic is reversed
The precise location in the horizontal and vertical planes of the right and left lateral port sites will be measured to assess port symmetry.
1 secondary outcome
Neuropathy
Time frame: Before, immediately after and 2 weeks after gynaecological surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Magos, MD FRCOG principal investigator
Royal Free Hamsptead NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior superior iliac spine in people with Surgical Techniques and Laparoscopy, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Magos, MD FRCOG (020 7794 0500 ext. 33863, a.magos@medsch.ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symmetry of lateral laparoscopic ports (time frame: On the completion of laparoscopy and before the general anaesthetic is reversed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2010.